American Regent Introduces Sodium Phosphates Injection, USP; FDA-Approved and "AP" Rated1
American Regent Introduces Sodium Phosphates Injection, USP; FDA-Approved and "AP" Rated1
SHIRLEY, N.Y., July 2, 2024 /PRNewswire/ -- American Regent announces the launch and availability of Sodium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Sodium Phosphates.1 Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
2024年7月2日，美国睿吉公司宣布推出并提供美国食品药品监督管理局批准的等效于磷酸钠的注射液，USP。.1磷酸钠注射液 USP 3 mM P/mL 可用作补充静脉大容量液的磷源，以预防或纠正限制或无口服摄入患者的低磷血症。当患者的需要无法通过标准电解质或营养液满足时，它还有用于制备特定的肠外营养液配方。
The concomitant amount of sodium
(Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
在制备这类溶液的总电解质剂量中，应计入同时摄入的钠离子（Na+）的量。
（Na+ 4 mEq/mL）+钠磷酸盐在高磷或低钙水平可能出现的疾病以及高钠血症患者中禁忌使用。
Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
在存在高磷或低钙水平的疾病以及高钠血症的患者中，磷酸钠禁忌使用。
"An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Sodium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc.
睿吉公司首席商务官兼副总裁Joann Gioia表示:“我们公司的使命之一是在可能的情况下，协助减轻药品短缺问题，确保关键药品的供应。为此，我们很高兴将磷酸钠注射液 USP 添加到我们坚实流畅的产品线中，这些产品均在我们的美国制造工厂里制备，灌装和完成。”
This product is available for immediate shipment. Customers can order Sodium Phosphates Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.
该产品可立即发货。客户可以通过其批发商/经销商或联系我们的客户支持组1-800-645-1706订购磷酸钠注射液 USP。磷酸钠注射液 USP顾客可以通过其批发商/经销商订购磷酸钠注射液 USP,或联系我们的客户支持组1-800-645-1706。.
Sodium Phosphates Injection, USP is supplied as follows:
磷酸钠注射液 USP如下：
|
NDC# |
Strength Pack |
Supplied as |
Shelf pack |
|
0517-7305-25 |
15 mM P/5 mL (3 mM P/mL) |
5 mL |
25 |
|
0517-7315-25 |
45 mM P/15 mL (3 mM P/mL) |
15 mL |
25 |
|
0517-7350-25 |
150 mM P/50 mL (3 mM P/mL) |
50 mL |
25 |
|
NDC# |
Strength Pack |
集装量 |
货架包装 |
|
0517-7305-25 |
15 mM P/5 mL (3 mM P/mL)，含20 mEq Na+/5 mL (4 mEq/mL) |
5毫升 |
25 |
|
0517-7315-25 |
每15毫升45毫摩尔磷(每毫升3毫摩尔磷) |
15毫升 |
25 |
|
0517-7350-25 |
每50毫升150毫摩尔磷(每毫升3毫摩尔磷) |
50毫升 |
25 |
See the following Important Safety Information, in addition to the product's Full Prescribing Information.
For additional information, please visit
请注意下面的重要安全信息，除了产品的完整处方信息。
获取更多信息，请访问
FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS
仅适用于在静脉输液液体中稀释后添加使用
INDICATIONS AND USAGE
Sodium Phosphates Injection, USP 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
LINZESS（linaclotide）适用于治疗成人肠易激综合征伴便秘（IBS-C）和慢性特发性便秘（CIC），以及6至17岁儿童和青少年的便秘功能障碍（FC）。不知道LINZESS在年龄小于6岁的FC儿童或IBS-C小于18岁的患者中是否安全和有效。
美国药典钠磷酸盐注射液，每毫升3毫摩尔磷，适用于大剂量静脉注射液中添加磷，以预防或纠正摄入受限或无法口服的低磷血症患者。当标准电解质或营养液溶液无法满足患者需要时，此药可作为添加剂使用。
The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
这些配好的溶液的总电解质剂量必须考虑钠(每毫升4毫当量)的同时加入量。+钠磷酸盐在高磷或低钙水平可能出现的疾病以及高钠血症患者中禁忌使用。
IMPORTANT SAFETY INFORMATION
重要安全信息
CONTRAINDICATIONS
Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
禁忌症
在存在高磷或低钙水平的疾病以及高钠血症的患者中，磷酸钠禁忌使用。
WARNINGS
Sodium Phosphates Injection, USP 3 mM P/mL must be diluted and thoroughly mixed before use.
警告
使用前必须将USP 3 mM P/mL磷酸钠注射液稀释并充分混合。
To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored.
为避免磷中毒，含有磷酸钠的溶液应缓慢注入。注入高浓度磷可能会降低血清钙和导致低钙性惊厥症状。应监测钙水平。
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
如有必要，在拥有水肿和钠滞留症状的患者中，应极度小心或尽量避免使用含钠离子的溶液。
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
对于肾功能减退的患者，使用含钠离子的溶液可能导致滞留钠离子。
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
警告：本产品含有可能具有毒性的铝。如果肾功能受损，则铝在长期静脉注射后可能达到有害水平。早产儿特别容易患上铝中毒，因为他们的肾脏未发育完全，需要大量含铝的钙磷溶液。
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
研究表明，肾功能受损的患者，包括早产儿，接受每天大于4到5微克/千克的静脉注射铝，会导致与中枢神经系统和骨骼毒性相关的铝积聚。即使在更低的注射速率下也可能发生组织负荷。
PRECAUTIONS
Do not administer unless solution is clear and seal is intact. Discard unused portion.
注意事项
仅当溶液清晰无颗粒并且密封完好才能使用，未用部分需丢弃。
Phosphorus replacement therapy with sodium phosphate should be guided primarily by the serum phosphorus level and the limits imposed by the accompanying sodium (Na+) ion.
钙（Ca）离子会影响磷（P）离子，应以血清磷水平为主导，考虑钠离子（Na）。+与肾功能不全、肝硬化、心力衰竭以及其他肿胀或滞留钠的情况下患者使用时需谨慎。
Use with caution in patients with renal impairment, cirrhosis, cardiac failure, and other edematous or sodium-retaining states.
爱的所有板块怀疑心患者，肾功能损害患者，肝硬化患者和处于肿胀或钠潴留状态患者的情况下使用含钠离子的溶液应小心使用。
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
静脉注射液，尤其是含钠离子的液体，注射给正在接受皮质类固醇或促肾上腺皮质激素的患者时应小心使用。
Pregnancy: Animal reproduction studies have not been conducted with sodium phosphate. It is also not known whether sodium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium phosphate should be given to a pregnant woman only if clearly needed.
有关使用BIKTARVY治疗妊娠期间的人类数据不足。与另一种整合酶抑制剂多烯伏格雷相关的有神经管缺陷的报道。讨论在怀孕和受孕期间使用BIKTARVY的效益风险。已建立抗逆转录病毒妊娠登记表。从FTC的APR获得的可用数据显示，先前未描述的畸形有与美国参考人群相比毫无差异的出生缺陷率。未进行磷酸钠的动物繁殖研究。还不知道磷酸钠是否会对孕妇造成胎儿损害或影响生殖能力。除非确实需要，否则不应给孕妇使用磷酸钠。
Pediatric Use: The safety and effectiveness of sodium phosphate has been established in pediatric patients (neonates, infants, children, and adolescents).
小儿用量：磷酸钠的安全性和有效性已在婴儿、儿童和青少年患者中得到证明。小儿用量：磷酸钠的安全性和有效性已在婴儿、儿童和青少年患者中得到证明。
Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
老年用药：对当前文献的评估未发现老年患者反应与年轻患者之间的差异。一般而言，应小心给老年患者选择剂量，通常在剂量范围的低端开始，反映出肝脏、肾功能或心功能的降低频率更高以及合并疾病或其他药物治疗的情况。鉴于钠离子和磷离子经肾脏大量排泄，因此，肾功能受损患者风险高，对该药物的毒性反应可能更大。由于老年患者肾功能受损的概率更高，因此在剂量选择方面应谨慎，并且可能有助于监测肾功能。
Sodium ions and phosphorus are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
未发现与磷酸钠有关的常见不良反应。
ADVERSE REACTIONS
Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany.
不良反应
不良反应包括可能引起的磷中毒。磷中毒导致血清钙减少，症状为低钙性惊厥。
OVERDOSAGE
In the event of overdosage, discontinue infusions containing sodium phosphate immediately and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum sodium levels. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.
过量剂量：如果过量剂量，则应立即停止含磷酸钠溶液的注入，并采取纠正疗法以恢复降低的血清钙和降低的血清钠水平。请参阅警告、注意事项和不良反应。
如出现超剂量，则应立即停止含磷酸钠的输液，并采取纠正疗法以恢复血清钙的降低以及降低血清钠水平的达到正常水平。请参阅警告、注意事项和不良反应。
For additional safety information, please see Full Prescribing Information.
有关更多安全信息，请查看 完整处方信息.
You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting or by calling 1-800-FDA-1088.
我们鼓励您向美国公司American Regent Inc.报告药品不良事件，电话是1-800-734-9236，或通过访问 或拨打1-800-FDA-1088进行举报。
You are encouraged to report adverse drug events (ADEs) to American Regent:
T 1.800.734.9236; E [email protected]; F 1.610.650.0170
我们鼓励您向美国公司American Regent报告药品不良事件：
T1.800.734.9236; E [email protected]; F1.610.650.0170
ADEs may also be reported to the FDA:
1.800.FDA.1088
or
药品不良事件也可以向FDA举报：
1.800.FDA.1088
或
Medical Information:
T 1.888.354.4855
(9:00 am–5:00 pm Eastern Time, Monday–Friday)
医疗信息：
电话：1.888.354.4855
（东部时间 上午9点至下午5点，周一至周五）
For medical information outside of normal business hours
that cannot wait until the next business day, please call 1.877.845.6371
若有医疗信息需询问，需在正常工作时间外，请拨打电话1.877.845.6371 。
如有紧急情况，请致电1.877.845.6371。
About American Regent
American Regent, Inc., a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy.
关于美国公司American Regent
美国公司American Regent，Inc.是大正制药集团（Daiichi Sankyo Group）的一家领先制剂制造商。 自50多年以来，美国公司American Regent一直在开发，制造和供应高质量的非专利和品牌主打的制剂制剂以回馈医疗保健工作者，包括近20年的静脉铁疗法领域。作为戴维三共集团公司的一员，美国再生已成为行业领先的注射剂生产商。超过50年来，美国再生一直致力于开发、制造和供应高质量的通用和品牌注射剂，服务于医疗保健提供商。20多年来，我们一直是IV铁疗法的领导者。
American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future.
美国公司American Regent致力于在美国制造。 因此，在过去几年中，我们在俄亥俄州和纽约州的制造设施扩大和现代化方面进行了重大投资。 这次扩张将使我们的产能增加近一倍，并使我们能够更好地为现在和未来的客户提供服务。
Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.
速度至关重要。 灵活性很重要。 可靠性和质量是最重要的。 因为患者不应该等待他们所需的药物。
For more information, please visit .
有关更多信息，请访问。
About Daiichi Sankyo Group
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society."
关于大正制药集团
戴养三共致力于利用我们的世界一流科学技术创造新的形式和创新药品，以实现我们的目标“为全球生活质量的提高做出贡献”。除了我们当前的肿瘤和心血管疾病药品组合外，戴养三共主要致力于开发新的治疗方案，针对患有高度未满足的医疗需求的癌症患者以及其他疾病。戴养三共拥有100多年的科学专业知识并在20多个国家设有分支机构，全球16000多名员工借力于丰富的创新遗产，实现我们的2030年愿景成为“一个为可持续发展做出贡献的创新全球医疗保健公司。”
For more information, please visit: .
欲了解更多信息，请访问:
All trademarks are the property of their respective owners.
所有商标均为其各自所有者的财产。
Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed April 12, 2024 .
参考资料: 1. Orange book: 获得治疗等效性评估的批准药物。美国食品和药物管理局。2024年4月12日查阅。
SOURCE American Regent Inc
来源美国摄影剂公司。